Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087955
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VITAMIN K1 PHYTONADIONE 10MG/ML INJECTABLE;INJECTION Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/25/1983 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/087955.PDF
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2004 SUPPL-17 Labeling

Label is not available on this site.

02/27/2003 SUPPL-15 Labeling

Label is not available on this site.

07/19/1999 SUPPL-14 Labeling

Label is not available on this site.

11/02/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

12/02/1993 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

08/28/1992 SUPPL-10 Labeling

Label is not available on this site.

12/28/1989 SUPPL-9 Labeling

Label is not available on this site.

08/15/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/19/1989 SUPPL-7 Labeling

Label is not available on this site.

02/22/1989 SUPPL-6 Labeling

Label is not available on this site.

11/04/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/04/1988 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/27/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/06/1983 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

VITAMIN K1

INJECTABLE;INJECTION; 10MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
PHYTONADIONE PHYTONADIONE 10MG/ML INJECTABLE;INJECTION Prescription No AB 207719 DR REDDYS LABS LTD
VITAMIN K1 PHYTONADIONE 10MG/ML INJECTABLE;INJECTION Prescription No AB 087955 HOSPIRA

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